Main info

Identificatie:

HOVON 54 MM

Sponsor:

HOVON

Included patients:

93

Active sites:

6

(of 6)

Title:

Non myeloablative allogeneic stem cell transplantation following high dose therapy as part of first line therapy to induce graft versus myeloma for patients <= 65 years participating in the HOVON 50 study.

Timeline

Flow

Details

Phase:

Prospective Phase II study

Monitoring Type:

Objectives:

Eligibility

Inclusion Criteria:

• Age 18-65 years inclusive;
• Included in the HOVON 50 MM study;
• Patient has received 3 cycles of VAD or AD+Thalidomide, CAD and 1 cycle of high dose Melphalan with autologous stem cell reinfusion according to HOVON 50 MM protocol;
• NMA allogeneic transplantation planned between 2 and 6 months after autologous stem cell reinfusion;
• WHO performance status 0-2;
• HLA-identical family donor;
• Written informed consent.

Donor Eligibility Criteria:

• HLA genotypically identical sibling;
• Informed consent to undergo G-CSF administration and leukapheresis;
• Adequate veins for leukapheresis or agrees to placement of central venous catheter;
• Willing and able to undergo apheresis procedure according to institutional guidelines.

Exclusion Criteria:

• Creatinin clearance < 50 ml/min;
• Severe cardiac dysfunction (NYHA classification II-IV, see appendix D) ;
• Significant hepatic dysfunction (serum bilirubin >= 30 micromol/l or transaminases >= 2.5 times normal level), unless related to myeloma;
• Patients known to be HIV-positive;
• Patients with active, uncontrolled infections;
• Progressive disease / relapse from CR / progression from MR or PR after HDM with autologous stem cell reinfusion according to HOVON 50 MM protocol.

Donor exclusion criteria:

• Monozygotic identical twin;
• Age less than 12 years;
• Pregnancy;
• Known allergy to G-CSF;
• HIV positive;
• Current serious systemic illness.

Participating Sites

= Active hospitals

= Inactive hospitals